The role will be responsible for helping to maintain the validation program including manufacturing, packaging, facilities, utilities, equipment, control systems, and processes at the Memphis facility.
The role will generate validation documentation and plan validation projects and manage daily control over large projects or many smaller capital projects which must be delivered to time and within budget. The role supports the continued necessary investment required for the site to stay competitive and to support compliance investment proposals to ensure the site is in alignment to GSK standards and national regulatory standards and codes.
•Write and execute IQ, OQ, and PQ protocols and summary reports for the facilities/utilities, manufacturing, and packaging areas as needed.
•Participates in Validation SOP development and the ongoing maintenance of the validated status of GXP systems.
•Responsible for driving all aspects of the Validation Life Cycle in Packaging and Utilities/Facilities from design through operation and improvement.
•Collaborates with Engineering on the development of installation and operation qualifications for equipment, utilities, and facilities.
•Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the validation team.
•Works closely with key stakeholder to determine and ensure project scope and scheduling.
•Support CAD files, program backups, project files and engineering documentation in an organized manner.
•Works with Technical services to produce the required validation documents: DS, IQ, OQ and PQ's.
•Develop Technical Change Controls for all projects managed as required.
•Develops with Customer input project briefs, User Requirements, Functional Specifications.
•Supports the sites technical or business processes to support the sites Engineering Improvement program and project ways of working.
•Promotes a safe environment with equipment and process designs and comply with all GSK quality and safety procedures and national and local regulations.
•Provide technical support and guidance to the operations team and attend production meetings, operations improvement meetings, and other departmental meetings as required.
•Assesses project resources for engineering capacity / capability and where required assess, appoint, control and direct specific Contractors and Suppliers.
•Acts as own planner / controller to produce schedules and detailed cost estimates and reports including full Tender Analyses
•Comply with all local, state and federal EHS laws and regulations, and all GSK Global EHS requirements.
•High School Diploma/GED
•3-5 years of validation experience in pharmaceutical or consumer healthcare industry
•Effective Strategic Communication skills -delivering written and oral communication with clarity and impact, tailored to the audience
•Strategic Customer Focus- taking initiative (a clearly interconnected set of activities) designed to raise the 'value added' for GSK to ensure a wider or long term effect/benefit
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires
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